FDA Approves Expanded Indication for Atogepant for Prevention of Chronic Migraine


Only the 60 mg dose of atogepant is approved for chronic migraine prevention.

The FDA has approved an expanded indication for atogepant (Qulipta) for the preventive treatment of migraine in adults, according to a press release.1

“Since September 2021, Qulipta has helped people living with episodic migraine prevent migraine attacks, reducing the daily burden of migraine. Now, those with the most challenging to treat chronic migraine can also rely on Qulipta to significantly reduce their migraine days,” said Roopal Thakkar, senior vice president and chief medical officer at AbbVie.

The expanded approval of atogepant makes AbbVie the first manufacturer to provide 3 treatments across the full spectrum of migraine disease; the company’s other migraine therapies include onabotulinumtoxin A (Botox)—the first FDA-approved preventive treatment for migraine—and ubrogepant (Ubrelvy), for acute treatment of migraine attacks.

“The FDA approval is an important milestone, providing those most impacted by migraine with a new, safe, and effective treatment option in a convenient, once-daily pill,” said Peter McAllister, MD, Director of the New England Center for Neurology and Headache.

The expanded indication was based on data from the pivolal phase 3 PROGRESS clinical trial (NCT03855137), which evaluated atogepant 60 mg once daily in adult patients with chronic migraine. The study met its primary endpoint of a statistically significant reduction from baseline in mean monthly migraine days vs placebo over a 12-week treatment period; data also showed that atogepant met all 6 key secondary endpoints, including those that measured the proportion of patients who achieved at least a 50% reduction in mean monthly migraine days during the study period.

These efficacy results are consistent with those found in the ADVANCE episodic migraine clinical trial (NCT03777059).

“Qulipta’s data demonstrate that it helps reduce the burden of migraine by delivering improvements in function, with high response rates and sustained efficacy over 12 weeks,” McAllister added. “These are critical factors neurologists and headache specialists consider when prescribing a treatment option, particularly for those with chronic migraine.”

Atogepant works by blocking calcitonin gene-related peptides through a once-daily dose. It is available in 10 mg, 30 mg, and 60 mg doses; only the 60 mg dose is indicated for preventive treatment of chronic migraine.

1. US FDA approves Qulipta (atogepant) for adults with chronic migraine. News release. AbbVie. April 17, 2023. Accessed April 19, 2023. https://news.abbvie.com/news/press-releases/us-fda-approves-qulipta-atogepant-for-adults-with-chronic-migraine.htm
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